Subacute and Chronic Non-specific Low Back PainLC OSTEONCT02034864

Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain

A study testing Osteopathic manipulative treatment in people with Subacute and Chronic Non-specific Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether a standardised osteopathic manipulative treatment is more effective than a placebo of osteopathic manipulative treatment, in sub-acute and chronic non-specific low back pain on functional recovery at 3 months. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Subacute and Chronic Non-specific Low Back Pain
What is being tested?: Osteopathic manipulative treatment
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 400 participants
Where: 1 siteFrance
Study dates: 17 Feb 2014to 23 Oct 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient consulting for subacute and chronic non-specific low
Male or female aged from 18 to 65 years (included)
Patient can speak and understand French
Patient giving his informed consent to participate in the study
Patient affiliated to or beneficiary of social insurance

Who cannot join

Specific low-back pain caused by inflammatory, tumoral, infectious disease or a back traumatism in the 3 past months
History of back surgery and/or vertebral fracture in the previous 6 months
Presence of a motor impairment related to the reason for consultation
The patient is a student or a practitioner in manipulative therapies
Pregnancy
Inability to understand the process of the study
The patient is already included in another clinical study

Trial locations and contacts

1 site in 1 country.

France1 site

CHU Cochin
Paris, 75014

Other trials in France

About this study

Official title: Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain at 3 Months : a Randomised Controlled Trial

Read the detailed description

Sub-acute (4-12-week duration) and chronic (more than 3-month duration) non-specific low back pain (LBP) is frequent, disabling and costly. The effectiveness of usual treatments (including pain killers, anti-inflammatory drugs, spinal injections, physiotherapy, spinal traction, transcutaneous electrical nerve stimulation, etc) may be not sufficient, and many patients resort to alternative therapies. Manipulative treatments represent en emerging therapy in this area, although studies assessing their effectiveness are limited and often biased. The purpose of this study is to evaluate the efficacy of two manual therapies on improving functional recovery in sub-acute and chronic non-specific low back pain at 3 months. A standardised osteopathic manipulative treatment is compare to a placebo of osteopathic manipulative treatment.

Conditions: Subacute and Chronic Non-specific Low Back Pain
Being tested: Osteopathic manipulative treatment, Placebo of osteopathic manipulative treatment
Keywords: low back pain, manual therapy, randomized controlled trial
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Osteopathic manipulative treatmentOther
A standardized manipulative treatment according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized manipulative treatment.
Placebo of osteopathic manipulative treatmentOther
A standardized placebo of manipulative treatment consisting in "light touch" and according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized placebo of manipulative treatment.

Study groups in NCT02034864
Study group	Role	What they receive
Osteopathic manipulative treatment	Experimental	6 sessions of standardized manipulative treatment Receives: Other: Osteopathic manipulative treatment
Placebo of osteopathic manipulative treatment	Sham comparator	6 sessions of standardized placebo of manipulative treatment Receives: Other: Placebo of osteopathic manipulative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean improvement from baseline in mean activity limitation
Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)
Measured: 3 months after randomization

Secondary outcomes (10)

Mean reduction from baseline in mean lumbar pain in the previous 48 hrs
assessed with a self-administered 11-class numeric scale (from 0 no pain to 100, maximal pain)
Measured: 3 months after randomization
Mean reduction from baseline in mean lumbar pain in the previous 48 hrs
assessed with a self-administered 11-class numeric scale (from 0, no pain to 100, maximal pain)
Measured: 12 months after randomization
Number of sick leaves
self-reported number of sick leaves
Measured: 12 months after randomization
Duration of sick leaves
self-reported total duration (days) of sick leaves
Measured: 12 months after randomization
Recurrence of pain
self-reported number of low back pain episodes
Measured: 12 months after randomization
Mean improvement from baseline in mean activity limitation
Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)
Measured: 12 months after randomization
Mean improvement from baseline in mean quality of life
Assessed with the physical and mental components of the self-administered MOS SF-12 questionnaire (from 0, worse quality of life to 100, best quality of life)
Measured: 3 months after randomization
Mean improvement from baseline in mean quality of life
Assessed with the physical and mental components of the self-administered MOS SF-12 questionnaire (from 0, worse quality of life to 100, best quality of life)
Measured: 12 months after randomization
Pain killer and non-steroidal anti-inflammatory drug consumption
self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no)
Measured: 3 months after randomization
Pain killer and non-steroidal anti-inflammatory drug consumption
self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no)
Measured: 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 201423 Oct 2017

First posted14 Jan 2014 (estimated)
Study start17 Feb 2014
Primary completion23 Oct 2017
Study completion23 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Subacute and Chronic Non-specific Low Back PainStudies of the same condition, open and under way.
More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02034864
Sponsor's protocol ID: P110142
Acronym: LC OSTEO
Status last verified: Aug 2025
First submitted: 10 Jan 2014
Last updated: 5 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

1. Poiraudeau S, Lefèvre-Colau M.-M, Fayad F., Rannou F, Revel M. Lombalgie. Encyclopédie Médico-Chirurgicale 15-840-C-10 (2004)
Chou R, Huffman LH; American Pain Society; American College of Physicians. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):505-14. doi: 10.7326/0003-4819-147-7-200710020-00008.
PubMed 17909211
Nelemans PJ, de Bie RA, de Vet HC, Sturmans F. WITHDRAWN: Injection therapy for subacute and chronic benign low-back pain. Cochrane Database Syst Rev. 2007 Jul 18;(2):CD001824. doi: 10.1002/14651858.CD001824.pub2.
PubMed 17636686
Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.
PubMed 15867409
Costa LO, Maher CG, Latimer J, Hodges PW, Herbert RD, Refshauge KM, McAuley JH, Jennings MD. Motor control exercise for chronic low back pain: a randomized placebo-controlled trial. Phys Ther. 2009 Dec;89(12):1275-86. doi: 10.2522/ptj.20090218. Epub 2009 Nov 5.
PubMed 19892856
Lambeek LC, van Mechelen W, Knol DL, Loisel P, Anema JR. Randomised controlled trial of integrated care to reduce disability from chronic low back pain in working and private life. BMJ. 2010 Mar 16;340:c1035. doi: 10.1136/bmj.c1035.
PubMed 20234040
Lindell O, Johansson SE, Strender LE. Subacute and chronic, non-specific back and neck pain: cognitive-behavioural rehabilitation versus primary care. A randomized controlled trial. BMC Musculoskelet Disord. 2008 Dec 30;9:172. doi: 10.1186/1471-2474-9-172.
PubMed 19116007
Macario A, Pergolizzi JV. Systematic literature review of spinal decompression via motorized traction for chronic discogenic low back pain. Pain Pract. 2006 Sep;6(3):171-8. doi: 10.1111/j.1533-2500.2006.00082.x.
PubMed 17147594
Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain. A meta-analysis of effectiveness relative to other therapies. Ann Intern Med. 2003 Jun 3;138(11):871-81. doi: 10.7326/0003-4819-138-11-200306030-00008.
PubMed 12779297
Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004 May-Jun;4(3):335-56. doi: 10.1016/j.spinee.2003.06.002.
PubMed 15125860
Manheimer E, White A, Berman B, Forys K, Ernst E. Meta-analysis: acupuncture for low back pain. Ann Intern Med. 2005 Apr 19;142(8):651-63. doi: 10.7326/0003-4819-142-8-200504190-00014.
PubMed 15838072
Rubinstein SM, van Middelkoop M, Kuijpers T, Ostelo R, Verhagen AP, de Boer MR, Koes BW, van Tulder MW. A systematic review on the effectiveness of complementary and alternative medicine for chronic non-specific low-back pain. Eur Spine J. 2010 Aug;19(8):1213-28. doi: 10.1007/s00586-010-1356-3. Epub 2010 Mar 14.
PubMed 20229280
Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. doi: 10.1186/1471-2474-6-43.
PubMed 16080794
Andersson GB, Lucente T, Davis AM, Kappler RE, Lipton JA, Leurgans S. A comparison of osteopathic spinal manipulation with standard care for patients with low back pain. N Engl J Med. 1999 Nov 4;341(19):1426-31. doi: 10.1056/NEJM199911043411903.
PubMed 10547405
Licciardone JC, Stoll ST, Fulda KG, Russo DP, Siu J, Winn W, Swift J Jr. Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1355-62. doi: 10.1097/01.BRS.0000067110.61471.7D.
PubMed 12838090

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain at 3 Months : a Randomised Controlled Trial
ClinicalTrials.gov ID: NCT02034864
Acronym / sponsor ID: LC OSTEO / P110142
Conditions: Subacute and Chronic Non-specific Low Back Pain
Keywords: low back pain, manual therapy, randomized controlled trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France, Université Paris Cité, University of Paris 5 - Rene Descartes, Institut Universitaire Romand de Sante au Travail, URC-CIC Paris Descartes Necker Cochin
Study start: 17 Feb 2014 (actual)
Primary completion: 23 Oct 2017 (actual)
Study completion: 23 Oct 2017 (actual)
First posted: 14 Jan 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Osteopathic manipulative treatment	Experimental	Other: Osteopathic manipulative treatment6 sessions of standardized manipulative treatment
Placebo of osteopathic manipulative treatment	Sham comparator	Other: Placebo of osteopathic manipulative treatment6 sessions of standardized placebo of manipulative treatment

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patient consulting for subacute and chronic non-specific low
Male or female aged from 18 to 65 years (included)
Patient can speak and understand French
Patient giving his informed consent to participate in the study
Patient affiliated to or beneficiary of social insurance

Key exclusion criteria (7 listed)

Specific low-back pain caused by inflammatory, tumoral, infectious disease or a back traumatism in the 3 past months
History of back surgery and/or vertebral fracture in the previous 6 months
Presence of a motor impairment related to the reason for consultation
The patient is a student or a practitioner in manipulative therapies
Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Osteopathic manipulative treatmentA standardized manipulative treatment according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized manipulative treatment.	Other	Osteopathic manipulative treatment
Placebo of osteopathic manipulative treatmentA standardized placebo of manipulative treatment consisting in "light touch" and according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized placebo of manipulative treatment.	Other	Placebo of osteopathic manipulative treatment

Primary outcome

Mean improvement from baseline in mean activity limitation
Time frame: 3 months after randomization
Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)

10 secondary outcomes

Mean reduction from baseline in mean lumbar pain in the previous 48 hrs
Time frame: 3 months after randomization
Mean reduction from baseline in mean lumbar pain in the previous 48 hrs
Time frame: 12 months after randomization
Number of sick leaves
Time frame: 12 months after randomization
Duration of sick leaves
Time frame: 12 months after randomization
Recurrence of pain
Time frame: 12 months after randomization
Mean improvement from baseline in mean activity limitation
Time frame: 12 months after randomization
Mean improvement from baseline in mean quality of life
Time frame: 3 months after randomization
Mean improvement from baseline in mean quality of life
Time frame: 12 months after randomization
Pain killer and non-steroidal anti-inflammatory drug consumption
Time frame: 3 months after randomization
Pain killer and non-steroidal anti-inflammatory drug consumption
Time frame: 12 months after randomization

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
Background1. Poiraudeau S, Lefèvre-Colau M.-M, Fayad F., Rannou F, Revel M. Lombalgie. Encyclopédie Médico-Chirurgicale 15-840-C-10 (2004)
Background: PubMed 17909211Chou R, Huffman LH; American Pain Society; American College of Physicians. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):505-14. doi: 10.7326/0003-4819-147-7-200710020-00008.
Background: PubMed 17636686Nelemans PJ, de Bie RA, de Vet HC, Sturmans F. WITHDRAWN: Injection therapy for subacute and chronic benign low-back pain. Cochrane Database Syst Rev. 2007 Jul 18;(2):CD001824. doi: 10.1002/14651858.CD001824.pub2.
Background: PubMed 15867409Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.
Background: PubMed 19892856Costa LO, Maher CG, Latimer J, Hodges PW, Herbert RD, Refshauge KM, McAuley JH, Jennings MD. Motor control exercise for chronic low back pain: a randomized placebo-controlled trial. Phys Ther. 2009 Dec;89(12):1275-86. doi: 10.2522/ptj.20090218. Epub 2009 Nov 5.
Background: PubMed 20234040Lambeek LC, van Mechelen W, Knol DL, Loisel P, Anema JR. Randomised controlled trial of integrated care to reduce disability from chronic low back pain in working and private life. BMJ. 2010 Mar 16;340:c1035. doi: 10.1136/bmj.c1035.
Background: PubMed 19116007Lindell O, Johansson SE, Strender LE. Subacute and chronic, non-specific back and neck pain: cognitive-behavioural rehabilitation versus primary care. A randomized controlled trial. BMC Musculoskelet Disord. 2008 Dec 30;9:172. doi: 10.1186/1471-2474-9-172.
Background: PubMed 17147594Macario A, Pergolizzi JV. Systematic literature review of spinal decompression via motorized traction for chronic discogenic low back pain. Pain Pract. 2006 Sep;6(3):171-8. doi: 10.1111/j.1533-2500.2006.00082.x.
Background: PubMed 12779297Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain. A meta-analysis of effectiveness relative to other therapies. Ann Intern Med. 2003 Jun 3;138(11):871-81. doi: 10.7326/0003-4819-138-11-200306030-00008.
Background: PubMed 15125860Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004 May-Jun;4(3):335-56. doi: 10.1016/j.spinee.2003.06.002.
Background: PubMed 15838072Manheimer E, White A, Berman B, Forys K, Ernst E. Meta-analysis: acupuncture for low back pain. Ann Intern Med. 2005 Apr 19;142(8):651-63. doi: 10.7326/0003-4819-142-8-200504190-00014.
Background: PubMed 20229280Rubinstein SM, van Middelkoop M, Kuijpers T, Ostelo R, Verhagen AP, de Boer MR, Koes BW, van Tulder MW. A systematic review on the effectiveness of complementary and alternative medicine for chronic non-specific low-back pain. Eur Spine J. 2010 Aug;19(8):1213-28. doi: 10.1007/s00586-010-1356-3. Epub 2010 Mar 14.
World Health Organization Benchmarks for training in osteopathy. Novembre 2010. Site Internet de l'Organisation Mondiale de la SantéLink provided by the sponsor.
Official Journal of the European Union Website. Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications p. 22-142Link provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Francois Rannou, MD PhD principal investigator

AP-HP, Descartes University, INSERM

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Osteopathic manipulative treatment in people with Subacute and Chronic Non-specific Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean improvement from baseline in mean activity limitation (time frame: 3 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02034864, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.